Packaging
A syringe should be
sealed in a primary container without affecting the
syringe in any way. The material sealing technique, etc.
should ensure sterility of the syringe and minimal risk of
contamination. Packing should give adequate protection
during handling, transit and storage. If opened, one
should not be able to reseal the package.
The packing material and
design of some brands was not designed to give them
adequate protection during handling, transit and storage.
The brands were rated and ranked on the basis of
weightages given to analytical parameters.
NEEDLES
Key Findings : Needles
6 brands of
22G needles and 7 brands of 23G needles were tested. Except one,
all the brands had 22G and 23G needles B-D and Sterican were
the top scorers in the 22G category, while Sterican was the top
scorer in the 23G category The prices of 22G and 23G of each
brand were the same One brand (23G) was found unsterile
All brands passed in the toxicity and pyrogen parameter One
brand was found to be unclean The joints of few brands
buckled under the force applied. |
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Needles
of various capacities are available in the market. They
are marked based on their gauges. The lower the gauge,
thinner the needle point. For general purposes, 23 G
needles are normally used. 22 G needles are also used but
mainly for injecting drugs which are more viscous or for
withdrawing fluid from the body.
How Sterile
Needles
must be sterile. Any bacterial or other contamination
could be easily transferred through the needle into the
body. Hence needles should maintain a high degree of
quality and purity, the absence of which could mean a
question of life and death for any patient.
Impurities
Manufacturers
have to ensure cleanliness of needles. Needles may attract
extraneous matter which could prove fatal for the patient.
The cleanliness of one brand was not found up to the mark
when observed physically.
Lubrication
Needles
are lubricated to facilitate greater ease of penetration.
However, excess lubricants remaining on the needle affect
the stability of the injection fluid.
The different Needle Parts
The
components of the needle include the needle tube, needle
hub and sheath. When it is observed the hubs of the
various brands of needles under a 2.5 magnifying lens,
foreign particles clinging to the hub sockets of few
brands were observed. Hence these brands did not conform
to the finish parameter. The joint between the hub and the
needle tube should be strong enough to resist breakage.
This test for strength of the joint ensures that the
needle would not separate while in operation. A force of
34 N on 23 G needles and 40 N on 22 G needles should be
applied on the joints of all brands. Much of the brands
buckled under the pressure applied, failing in the needle
assembly parameter. Needle tube dimensions include the
length, diameter and bore of the needle tube.
Are the Markings OK?
The
length and diameter of the needle tube, expressed in mm
should be mentioned on individual unit containers. Ten of
them did not conform to this requirement for size
designation. For each corresponding dimension, the IS
prescribes a specific colour coded hub. The container of
each needle should be marked with the description of the
contents, including the size designation, the word sterile,
the name and/or trademark of manufacturer, supplier and
the batch number or date of manufacturing.
Packaging
The IS
requires, among other packaging requirements, a visible
colour coding on the packet.
How they Rated
The
needles are rated and ranked based on parameters which
were given weightage according to their importance.
INSULIN SYRINGES
Key Findings : Insulin Syringes
3 brands of U-100
and 5 brands of U-40 of insulin syringes were tested
B-D was the top scorer in the U-100 segment,
Dispovan and B-D were the top scorers in the U-40
category None of the brands met the requirements
of markings specified by the IS 2 brands could
not meet the BIS specifications for graduated scale. |
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Diabetes
has become a major health concern in India with over two
million people estimated to be afflicted with this disease
every year. Diabetes is a hormonal disorder, which is
caused by the inability of the body to either produce
insulin or utilise it properly. Deficiency of insulin
leads to high levels of sugar in the blood. However,
insulin cannot be administered orally to patients as the
stomach acid denatures it. It needs to be injected into
the body.
Most
diabetics either take injections on their own or get
someone at home to administer at. Siliconised needles (29
G) integrated with the barrel of the syringe are normally
used for injecting insulin. Insulin syringes are smaller
than the normal syringes, not exceeding one ml in
capacity. Unlike normal syringes, insulin syringes are
graduated in units and not in ml. They are available as
either 40 units or 100 units.
Marking
Certain
markings are mandatory on the insulin syringe. These
include graduated scale capacity, scale interval, the
words U-40 or U-100, the words UNITS or IU, graduated
capacity in ml, etc. Some of the brands meet all the
marking requirements prescribed by the IS.
Packaging
As per
the packaging requirements of the BIS, there are certain
standards to be maintained for the packing of insulin
syringes, both in terms of the material used and the
design used for packing. The nature of sealing is also
very important. Some brands could not conform to the above
specifications.
Graduated Scale
The
Indian Standards lay down strict norms for the graduation
of insulin syringes, both in terms of the scale and its
numbering. The requirements cover the units of graduation,
their legibility, spacing, accuracy, uniformity, the
position and method of numbering, etc. Graduation lines
should be clearly defined, legible and of uniform
thickness, lying in planes at right angles to the axis of
the barrel.
Size of Needle
The IS
has specific requirements for the length of the needle in
an insulin syringe. It should be at least 12 ml. Few
brands did not have the minimum needle length prescribed
by the IS. The IS also specifies a diameter for the bore
of the needle tube to facilitate a smoother flow of the
injection fluid.
How they Rated
They are
rated and ranked based on weightages according to
analytical parameters.
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